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the success, cost and timing of our product development activities and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; |
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our ability to advance any product candidate into or successfully complete any clinical trial; |
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our ability or the potential to successfully manufacture our product candidates for clinical trials or for commercial use, if approved; |
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the potential for our identified research priorities to advance our technologies; |
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our ability to obtain and maintain regulatory approval, if obtained, of AKR-001 or any future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; |
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the ability to license additional intellectual property relating to any future product candidates and to comply with our existing license agreement; |
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our ability to commercialize our products in light of the intellectual property rights of others; |
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the success of competing therapies that are or become available; |
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our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; |
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the commercialization of our product candidates, if approved; |
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our plans to research, develop and commercialize our product candidates; |
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our ability to attract collaborators with development, regulatory and commercialization expertise; |
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future agreements with third parties in connection with the commercialization of our product candidates and any other approved product; |
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the size and growth potential of the markets for our product candidates, and our ability to serve those markets; |
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the rate and degree of market acceptance of our product candidates; |
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regulatory developments in the United States and foreign countries; |
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our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; |
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our ability to attract and retain key scientific or management personnel; |
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the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; |
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the impact of laws and regulations; and |
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our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates. |